IMPLANTABLE SUPPORT DEVICE

Abstract: Implantable support device to support a weakened region of a human or animal body wall and comprising at least two expandable balloons of a non-absorbable biocompatible material and being mutually connected by means of a tube or a pipe, wherein at least the one expandable balloon comprises a valve that permits inflow and prevents outflow of expansion agent and which is in communication with separable means for the supply of expansion agent.

Description: IMPLANTABLE SUPPORT DEVICE The present invention relates to an implantable support device for supporting a weakened region of a human or animal body wall and comprising an expandable portion and means for supplying expansion agent thereto. Hernia is a pouching in the wall of a body cavity, e.g. the abdominal wall. The pouching, the hernial sac, of the abdominal wall usually contains organ portions, e.g. portions of the small intestine. The opening in the abdominal wall is referred to as the hernial opening, and when it is elongated it is referred to as the hernial channel. The surgical treatment of hernia (herniato ia) consists in moving the hernial sac out of the hernial channel and away from the hernial opening, following which the abdominal wall is to be reinforced at the hernial opening. Such reinfor¬ cement may be obtained by stitching pieces of the patient's own tissue across the hernial opening. If, following the first surgical treatment, the hernia re-forms the surgeon may chose to implant a woven web of artificial fibres or a sheet of artificial fibres. However, this requires that a consi¬ derable opening is formed in the abdominal wall of the patient. In order to avoid such comprehensive surgical intervention, surgeons have taken to use the more recent laparoscopic operation technique whereby operation is carried out through one or more small incisions through the skin into the abdominal wall by means of an endoscope and one or more working ducts in the form of thin pipes and instruments adapted therefor. This operation technique requires that all the utensils necessary for the operation can be introduced into the abdominal cavity and manipulated therein through said working ducts in the form of thin pipes. In connection with the use of said operation technique it is known to fill the hernial channel with a plug of rolled-up gauze following which the hernial opening is blocked with a web material which is spread across the hernial opening by means of thongs and subsequently secured to the abdominal wall by means of suture or plastics or metal clips. DK patent application No. 1914/91 describes a support device for supporting a weak area of a patient's abdominal wall and comprising a foldable web and thread-like braces which are designed to maintain the web unfolded in their unloaded or slightly loaded states and simultaneously permitting such folding up of the web that it may be introduced into the abdominal cavity through a comparatively thin pipe. US patent No. 5,176,692 describes a method and an instrument for use in the method for the treatment of hernia. In this known method an instrument is used which comprises a tube and an inflatable balloon which is secured to the distal end of the tube. The balloon is made of a bioabsorbable or bio- dispersible material, and a flexible net of biologically inactive material may be secured to the balloon. The net may be provided with a large number of protrusions or fingers which serve to fix the net relative to the hernial opening. When using this known instrument, the balloon and the net enveloping the ballon are introduced into a hernial sac from the abdominal cavity and the balloon is caused to expand by supplying thereto an expansion agent, such as air, through the tube. Following expansion of the ballon, the tube is caused to shrink and thus the tube is closed proximally of the balloon and the portion of the tube which is proximal to the shrinking site is separated from the remaining portion and removed. As a supplement the net may be arranged across the hernial opening. It applies to most known and used support devices that they do not completely repair the condition, and that recidivation often occurs. The invention is based on the discovery that the treatment of hernia should not be carried out only by blocking the hernial opening following removal from the hernial sac of any prolapsed organs, but that it is also important to stimulate the tissue around the hernial opening to form scar tissue and thus to reinforce this area to prevent renewed prolapse, and that such stimulation of scar tissue formation may be obtained by positioning expanded balloons on both sides of the hernial opening. Thus, the support device according to the invention is characterized in that it comprises at least two expandable film bodies made from a non-absorbable biocompatible material and mutually connected through at least one tube or pipe wherein at least the one expandable body is connected to separable means for the supply of expansion agent through a valve which permits inflow and prevents outflow of expansion agent. When using the support device according to the invention for laparoscopic herniotomia, the two utua?. ~ y connected ex¬ pandable bodies, in the following referred to as balloons, are rolled up and are together with the distal portion of the means for the supply of expansion agent, moved through a working duct in the form of a thin pipe into the abdominal cavity, while the proximal end of the supply means remains outside the patient. By means of a catching tool which e.g. is manipulated through a second working duct, the balloons can be arranged in such a manner that they are located on either side of the hernial opening of the hernial sac from which prolapsed organs have been removed. Expansion agent is subsequently supplied until a suitable expansion of both balloons is obtained. Finally, the supply means are released from the balloon to which they are connected, preferably by a slight pull, and they may subsequently be removed from the patient. Although the use of the support device according to the invention has been described above in connection with a laparoscopic herniotomia, it should be understood that it may also be used in connection with other types of herniotomiae. The balloons of the support device thus arranged ensure that it is safely fastened around the hernial opening and will thus prevent renewed prolapse of organ portions. Moreover, the described fastening will cause at least the one balloon to rub slightly against the abdominal wall around the hernial opening when the patient moves and this rubbing effect will stimulate the formation of reinforcing scar tissue in this area. When the strength of the abdominal wall in this area has been increased sufficiently to eliminate any danger of renewed prolapse of organ portions, the support device may be removed, e.g. laparoscopically. This may be effected by perforation of one of the balloons with a syringe and/or extraction of the expansion agent. This causes the balloons to collapse and the support device may subsequently be removed from the abdominal cavity and from the patient through the working duct of the laparoscope by means of suitably designed catching thongs. US patent No. 5,211,624 describes a surgical closure device suitable for closing e.g. a perforated gallbladder. The closure device comprises a rigid tube, a proximal and a distal expandable ballon attached to one end of the tube and two supply tubes for expansion agent which are in communica¬ tion with the rigid tube and extend parallel therewith and which at their distal ends debouch in each their balloon. When the closure device is to be used, the distal end of the rigid tube is moved so far into the gallbladder perforation that the distal balloon is located on the inside of the perforated portion of the balloon and the proximal balloon on the outside. Supply of expansion agent to the two balloons will cause both to expand and abut on the gallbladder wall from opposite sides thereof and thus to isolate the perfora¬ tion therein. If desired, the rigid tube and the two supply tubes may be cut off and closed at a short distance from the proximal balloon. The known closure device does not comprise a duct which connects the balloons to each other and it is not intended that the balloons shall be able to move relative to the adjacent tissue following expansion. The balloons which are part of the support device according to the invention conveniently consist of an expandable plastics sheet material, preferably a polyurethane film. Polyurethane films are flexible and dermatologically compa¬ tible. The balloons may also consist of a plastics film which is substantially non-extendable. Such balloons present the advantage that their volumes do not change substantially when the normal working pressure is moderately exceeded. For this purpose it is particularly convenient to use plastics sheet laminates comprising a layer of an extendable film and a second layer of a non-extendable film. A plastics sheet laminate of a polyurethane film which is dermatologi- cally compatible and a nylon film which has poor extendabili- ty are particularly suitable. The film material from which the balloons are made must be proof to the expansion agent used. This is preferably a gas, such as air, but non-gaseous expansion agents, such as a liquid, a gel or a powder, may also be used. The valve in the one balloon is preferably an automatically operating one-way valve, e.g. of the type that comprises a valve body which, under the influence of a helical spring, is kept in abutment with a valve seat when in its resting position. The separable means for the supply of expansion agent preferably consist of a plastics tube which may be removed by a slight pull. The tube or the pipe between the two ex- pandable balloons are preferably also made of plastics. A preferred embodiment of the support device according to the invention which may be used to support large areas of weakened tissue comprises a first balloon and two or more additional balloons, preferably smaller than the first, and wherein each of the additional ballons is in communication with the first balloon through a tube or a pipe. When using this embodiment the additional (smaller) balloons are located as fastening means in the tissue around the weakened area in such a manner that the first balloon covers the weakened area. The first balloon is conveniently wheel-shaped. The invention will now be described in further detail with reference to the drawings, wherein Fig. 1 is a sectional view of a preferred embodiment of a support device according to the invention prior to use and located in an insertion tube, Fig. 2 is a side view of the support device shown in fig. 1 in its inflated state, Fig. 3 is a schematical, sectional view of a hernial sac. Figs. 4-6 are schematical views of various applications for a support device according to the invention for the treatment of hernia, Fig. 7 is a partial sectional view of a balloon having a one-way valve secured thereto and a tube for the supply of expansion agent, Fig. 8 is a top plane view of a further embodiment of a support device according to the invention, and Fig. 9 is a schematical view of the support device shown in fig. 8 used to support a weakened region of a body wall. The device shown in fig. 1 comprises a first expandable balloon 1 which is in communication with a tube 2 for the supply of expansion agent, such as air, through a one-way valve (not shown) . The balloon 1 is in communication with a second expandable balloon 4 through a thin connecting tube 3. The two mutually connected balloons l and 4 are in their deflated states arranged in an insertion tube 5 and the distal end of a pushing device 6 which debouches in a horseshoe-shaped means 7 is also inserted therein. The support device shown in fig. 2 consists of two annular expanded balloons 10 and 11 which are mutually connected through a connecting tube 12. The supporting means also comprises a one-way valve (not shown) through which expansion agent has been supplied to expand the two balloon:-, 10 and 11 and radially extending ducts (not shown) throu which the annular balloons 10 and 11 are in communication with the ends of the connecting tube 12. Fig. 3 shows a peritoneum 20 situated between an abdomen 21 and an abdominal wall 22 which is adjacent to a skin layer 23. As will appear from fig. 4 the peritoneum 21 has formed a hernial sac 24 with a hernial opening 25. The support device shown in fig. 4 corresponds to the one shown in fig. 2 and thus comprises two expandable annular balloons 30 and 31 which are mutually connected through a connecting tube 32. As will appear from fig. 4 the larger of the two balloons 31 is located in a hernial sac 33 formed by a peritoneum 34 and in an abdominal wall 35 with a skin layer 36 and such that the connecting tube 32 passes through a hernial opening 37, and the balloon 30 is located in an abdomen 38. As a result of the balloons 30 and 31 being in communication with the peritoneum 34 in the region around the hernial opening 37 and during the movements of the patient rubbing against the peritoneum, scar tissue is formed in the contact zones which reinforces the peritoneum and thus prevents prolapse of organ portions upon removal of the support device. The support device shown in fig. 5 comprises two relatively flat expanded balloons 40 and 41 with a connecting tube 42. The smaller of the two balloons 40 is arranged in the abdominal wall 35 and the connecting tube extends through an opening in the peritoneum 34 and the hernial sac 33 into the abdomen 38. In fig. 6 a hernial sac 33 is shown which is located in the abdomen 38 and containing a balloon 50 which, through an connnecting tube 51, is in communication with a second balloon 52 arranged in the abdominal wall 35 within the skin layer 36 and serving as a fastening means for the balloon 50. Fig. 7 shows a balloon 60, an orifice 61 across which a coupling means 62 with an internal duct is secured, one end of said duct 63 having such a shape that it allows the introduction of the end of a connecting piece 64 which is secured to the end of a tube 65 for supplying expansion agent to the balloon 60. A one-way valve, which is generally designated 66, is provided at the opposite end of the internal duct in the coupling r ,:ans 62, said one-way valve comprising a valve connecting piece 67 and a valve housing 68 including a valve seat 69, a valve body 70 which is maintai¬ ned in abutment with the valve seat 69 by means of a helical spring 71 that is secured in the valve housing by a plug 72. When the support device described above is implanted, the connecting piece 64 is introduced into the end 63 of the internal duct of the coupling means and an expansion agent, such as atmospheric air, is introduced u rler pressure into the coupling means 62 thereby causing the v.lve body 70 to be displaced relative to the valve seat 69 and the air to flow into the balloon 70. When the pressurized air supply is discontinued the valve 66 closes and the air is thus prevented from flowing out of the balloon 60. The support device shown in figs 8 and 9 comprises a first wheel-shaped balloon 80 having a centrally located one-way valve (not shown) and four anchoring balloons 81 which are connected to the wheel-shaped first balloon 80 by means of connecting tubes 82. As shown in fig. 9 the balloon 80 described in fig. 8 may be used to support a weakened region 83 of a peritoneum 84, the wheel-shaped first balloon 80 being arranged to cover the weakened region 83 of the peritoneum 83, and the anchoring balloons being arranged in an abdominal wall 84 and in their expanded states fixing the support device relative to the weakened region 83 of the peritoneum.

Claims: C l a i m s 1. Implantable support device to support a weakened region of a human or animal body wall comprising an expandable portion and means for supplying expansion agent thereto, c h a r a c t e r i z e d in that it comprises at least two expandable film bodies made of a non-absorbable, biocompa¬ tible material and mutually connected through at least one tube or pipe, at least the one expandable body being connec¬ ted to separable means for the supply of expansion agent through a valve that permits inflow and prevents outflow of expansion agent. 2. Support device according to claim 1, c h a r a c ¬ t e r i z e d in that the expandable body consists of an expandable plastics film. 3. Support device according to claim 1, c h a r a c ¬ t e r i z e d in that the expandable body consists of a plastics film which is substantially non-expandable. 4. Support device according to claim 1, c h a r a c ¬ t e r i z e d in that the expandable body consists of a plastics sheet laminate. 5. Support device according to claim 2, c h a r a c ¬ t e r i z e d in that the expandable body consists of a laminate of a polyurethane film. 6. Support device according to claim 4, c h a r a c ¬ t e r i z e d in that the expandable body consists of a laminate of a polyurethane film and a nylon film. 7. Support device according to any one of the preceding claims, c h a r a c t e r i z e d in that the tube or pipe that connects the two expandable sheet bodies is made of plastics. 8. Support device according to any one of the preceding claims, c h a r a c t e r i z e d in that the valve comprises a valve body which in its resting position is maintained in abutment with a valve seat by means of a helical spring. 9. Support device according to any one of the preceding claims, c h a r a c t e r i z e d in that the separable means for the supply of expansion agent is constituted of a tube which is removable by a slight pull. 10. Support device according to any one of the preceding claims, c h a r a c t e r i z e d in that it comprises a first expandable sheet body of two or more additional expandable sheet bodies each of which is in communication with the first expandable body through a tube or a pipe.

Inventors: NIEBEN OLE GYRING, NIEBEN, OLE, GYRING
Applicants: EL DOT KS, NIEBEN OLE GYRING, EL-DOT KS, NIEBEN, OLE, GYRING
Application year: 1994
Main classification: A61F2
IPC codes: A61B19, A61F2